An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Intra-venous Implantation of Autologous Adipose-Derived Stem Cells in Patients With Frailty Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Improvement in Physical Performance Test (PPT) Results
研究概览
简要总结
The intent of this clinical study is to answer the questions:
- Is the proposed treatment safe
- Is treatment effective in improving the health of patients with human frailty syndrome.
详细描述
This will be an open-label, non-randomized multi-center patient sponsored study of Autologous Adipose-Derived Stem Cells (ASC) implantation after liposuction using an IV delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered intravenously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females Age >
- •Frailty syndrome defined by:
- •BMD< T-1 (Based on QCT results) Body Mass: males <8% or >17% fat, females<10% or>24% fat (Lean Body Mass=Total Body Mass- %Body Fat)
- •Ability to participate in the short physical performance battery
- •Up to date on all age and gender appropriate cancer screening per American Cancer Society
排除标准
- •Life expectancy < 6 months due to concomitant illnesses.
- •Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- •Active infectious disease patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis. will have an expert consulted as to patient eligibility based on the patient's infectious status
- •Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- •Patients on chronic immunosuppressive transplant therapy
- •Active clinical infection being treated by antibiotics within one week of enrollment.
- •Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- •History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- •Unwilling and/or not able to give written informed consent.
结局指标
主要结局
Improvement in Physical Performance Test (PPT) Results
时间窗: 6 months
Number of Adverse Events Reported
时间窗: up to 6 months
The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 6-month period following treatment.
Improved body composition/bone density compared to baseline
时间窗: 6 months
Quality of life is improved compared to baseline
时间窗: 6 months
Improved body composition/bone density compared to baseline
时间窗: 3 months
Improvement in Physical Performance Test (PPT) Results
时间窗: 3 months
Quality of life is improved compared to baseline
时间窗: 3 months
次要结局
- Improved exercise capacity compared to baseline(6 months)
- Improved exercise capacity compared to baseline(3 months)